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Trial registered on ANZCTR


Registration number
ACTRN12618001910291
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
23/11/2018
Date last updated
13/05/2019
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Protein/Creatinine ratio versus 24-Hour urine protein in preeclampsia
Scientific title
Accuracy of protein/Creatinine ratio versus 24-Hour urine protein in preeclampsia in detection of remarkable proteinuria in preeclampsia.
Secondary ID [1] 296609 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 310417 0
Condition category
Condition code
Reproductive Health and Childbirth 309131 309131 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 309170 309170 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Preeclampsia defined as the presence of hypertension and urinary proteins after 20 weeks` gestation. Hypertension defined as blood pressure more than or equal 140/90 mmHg. Urinary protein defined as the presence of more than or equal 300 mg protein in the 24-hour collected urine and/or a positive urine dipstick test.
The studied women will be admitted for moderate 24 hours bed rest, control of blood pressure and for the 24-hour urine collection for assessment of proteinuria, which started on the morning following the hospitalization.
Spot mid-stream urine specimens (first morning urine sample) for measuring protein/creatinine ratio will be obtained shortly before the 24-hour urine collection.
Urinary protein will be determined by the Biuret method.
Urine creatinine level will be measured by a modified Jaffe test.
Intervention code [1] 312916 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308114 0
Accuracy of protein to creatinine ratio versus 24-hour urine collection in detection of remarkable proteinuria in preeclampsia.
Urine protein will be assessed by Biuret method.

Timepoint [1] 308114 0
The results of urine protein will be ready within 15 minutes for each patient.
While, the time point for assessment of the study outcome will be available post-enrolment.
Secondary outcome [1] 353982 0
Urine creatinine will be assessed by modified Jaffe test.
Timepoint [1] 353982 0
The results of urine creatinine will be ready within 15 minutes for each patient.
While, the time point for assessment of the study outcome will be available post-enrolment.

Eligibility
Key inclusion criteria
Women between 20-40 years old, diagnosed as preeclampsia and admitted for control of blood pressure and investigations after 20 weeks` gestation during the period from December 2018 till December 2019 after informed consent and approval of the study by the local ethical committee of both hospitals.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women > 40 years, women with chronic hypertension, gestational hypertension (without proteinuria), diabetes, pre-existing chronic renal disease or urinary tract infections, refused to participate and/or refused to give consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Accuracy will be detected after calculation of the sensitivity: is the proportional detection of individuals with the disease of interest in the population.
Specificity: is the proportional detection of individuals without the disease of interest in the population.
Positive predictive value (PPV): is the proportion of all individuals with positive tests, who have the disease. Negative predictive value (NPV): is the proportion of all individuals with negative tests who are non-diseased.
Sensitivity = true positive / true positive + false negative X 100
Specificity = true negative / true negative + false positive X 100
Positive predictive value = True positive / (True positive + false positive) X 100
Negative predictive value = True negative / (True negative + false negative) X 100
Accuracy = True positive + true negative / (True positive + true negative + false positive + false negative) X 100

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21038 0
Kuwait
State/province [1] 21038 0
Ahmadi hospital, Ahmadi, Kuwait.
Country [2] 21039 0
Kazakhstan
State/province [2] 21039 0
West Kazakhstan State Medical University

Funding & Sponsors
Funding source category [1] 301187 0
Hospital
Name [1] 301187 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address [1] 301187 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 301187 0
Kuwait
Funding source category [2] 301188 0
University
Name [2] 301188 0
West Kazakhstan State Medical University , Aktobe, Kazakhstan
Address [2] 301188 0
RSE on REU West Kazakhstan Marat Ospanov State Medical University.
MH RK Republic of Kazakhstan, Aktobe, Maresyev Street 68.
PO BOX Aktobe 030012
Country [2] 301188 0
Kazakhstan
Primary sponsor type
Individual
Name
Ibrahim A. Abdelazim
Address
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country
Kuwait
Secondary sponsor category [1] 300809 0
Individual
Name [1] 300809 0
Svetlana Shikanova
Address [1] 300809 0
RSE on REU West Kazakhstan Marat Ospanov State Medical University.
MH RK Republic of Kazakhstan, Aktobe, Maresyev Street 68.
PO BOX Aktobe 030012
Country [1] 300809 0
Kazakhstan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301927 0
Head of the Obstetrics, and Gynecology department, Ahmadi hospital, Kuwait.
Ethics committee address [1] 301927 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 301927 0
Kuwait
Date submitted for ethics approval [1] 301927 0
02/10/2018
Approval date [1] 301927 0
23/10/2018
Ethics approval number [1] 301927 0
Ethics committee name [2] 301928 0
Head of the department of Obstetrics and Gynecology of Marat Ospanov, West Kazakhstan State Medical University (WKSMU), Aktobe, Kazakhstan
Ethics committee address [2] 301928 0
RSE on REU West Kazakhstan Marat Ospanov State Medical University. MH RK Republic of Kazakhstan, Aktobe, Maresyev Street 68.
Ethics committee country [2] 301928 0
Kazakhstan
Date submitted for ethics approval [2] 301928 0
02/10/2018
Approval date [2] 301928 0
23/10/2018
Ethics approval number [2] 301928 0

Summary
Brief summary
A complete obstetrical history, clinical examination and laboratory investigations will be done to the studied women to exclude the conditions affecting urinary protein/creatinine ratio (as chronic renal disease).
The studied women will be admitted for moderate 24 hours bed rest, control of blood pressure and for the 24-hour urine collection for assessment of proteinuria, which started on the morning following the hospitalization.
Spot mid-stream urine specimens (first morning urine sample) for measuring protein/creatinine ratio will be obtained shortly before the 24-hour urine collection.
Collected data at the end of the study will statistically analyzed to evaluate the accuracy of protein to creatinine ratio versus 24-hour urine collection in detection of remarkable proteinuria in preeclampsia.
Trial website
None
Trial related presentations / publications
None
Public notes
A complete obstetrical history, clinical examination and laboratory investigations will be done to the studied women to exclude the conditions affecting urinary protein/creatinine ratio (as chronic renal disease).
The studied women will be admitted for moderate 24 hours bed rest, control of blood pressure and for the 24-hour urine collection for assessment of proteinuria, which started on the morning following the hospitalization.
Spot mid-stream urine specimens (first morning urine sample) for measuring protein/creatinine ratio will be obtained shortly before the 24-hour urine collection.
Collected data at the end of the study will statistically analyzed to evaluate the accuracy of protein to creatinine ratio versus 24-hour urine collection in detection of remarkable proteinuria in preeclampsia.

Contacts
Principal investigator
Name 88590 0
Prof Ibrahim A. Abdelazim
Address 88590 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 88590 0
Kuwait
Phone 88590 0
+96566551300
Fax 88590 0
Email 88590 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 88591 0
Prof Ibrahim A. Abdelazim
Address 88591 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 88591 0
Kuwait
Phone 88591 0
+96566551300
Fax 88591 0
Email 88591 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 88592 0
Prof Ibrahim A. Abdelazim
Address 88592 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 88592 0
Kuwait
Phone 88592 0
+96566551300
Fax 88592 0
Email 88592 0
dr.ibrahimanwar@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Start date 4/11/2019
End date 4/5/2020
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 251 0
Study protocol
Citation [1] 251 0
Link [1] 251 0
Email [1] 251 0
Other [1] 251 0
Type [2] 253 0
Ethical approval
Citation [2] 253 0
Link [2] 253 0
Email [2] 253 0
Other [2] 253 0
Summary results
No Results